Dosing & Uses
Dosage Forms & Strengths
tablet
- 25mg
- 50mg
Hypertension (HTN)
Initial 50 mg PO qDay; may increase to 50 mg PO q12hr; may take up to four weeks for full therapeutic response; hyperkelemia may occur with doses >100 mg/day
Heart Failure Post MI
Initial 25 mg PO qDay; may titrate to maximum of 50 mg once daily within 4 weeks as tolerated
Dose adjustments may be required based on potassium levels
Renal Impairment
Contraindicated if CrCl <50 mL/min or serum creatinine >2 mg/dL in males or >1.8 mg/dL in females
Hepatic Impairment
Dose adjustment not necessary
Dosing considerations
In post-MI CHF patients taking a moderate CYP3A inhibitor, do not exceed 25 mg once daily; in patients with hypertension taking a moderate CYP3A inhibitor, initiate at 25 mg once daily; for inadequate blood pressure response, dosing may be increased to a maximum of 25 mg twice daily
Other Indications and Uses
Improving survival of stable patients with LV systolic dysfunction (LVEF ≤40%) and CHF after an acute myocardial infarction (MI)
Safety and efficacy not established
Hypertension
Initial 50 mg PO qDay; may increase to 50 mg PO q12hr; may take up to four weeks for full therapeutic response; hyperkelemia may occur with doses >100 mg/day
Heart Failure Post MI
Initial 25 mg PO qDay; may titrate to maximum of 50 mg once daily within 4 weeks as tolerated
Dose adjustments may be required based on potassium levels
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
1-10%
Hyperkalemia (2-10%)
Increased risk of hyperkalemia with presence of renal dysfunction
1-3%
- Dizziness
- Fatigue/malaise
- Abdominal pain
- Diarrhea
- Albuminuria
- Hypercholesterolemia
- Hypertriglyceridemia
- Cough
<1%
Abnormal vaginal bleeding
Gynecomastia
Mastodynia
Warnings
Contraindications
Hypersensitivity
For all patients: Serum potassium >5.5 mEq/L at initiation Creatinine clearance ≤30 mL/min Concomitant use with strong CYP3A inhibitors For the treatment of hypertension: Type 2 diabetes with microalbuminuria Serum creatinine >2.0 mg/dL in males, >1.8 mg/dL in females Creatinine clearance <50 mL/min Concomitant use of potassium supplements or potassium-sparing diuretics
For all patients
- Serum potassium >5.5 mEq/L at initiation
- Creatinine clearance ≤30 mL/min
- Concomitant use with strong CYP3A inhibitors
For the treatment of hypertension
- Type 2 diabetes with microalbuminuria
- Serum creatinine >2.0 mg/dL in males, >1.8 mg/dL in females
- Creatinine clearance <50 mL/min
- Concomitant use of potassium supplements or potassium-sparing diuretics
Cautions
Hyperkalemia, liver dysfunction, metabolic or respiratory acidosis, renal impairment, hypersensitivity to spironolactone
The risk of hyperkalemia is higher in patients with impaired renal function, proteinuria , diabetes and those concomitantly treated with ACEs, ARBs, NSAIDs and moderate CYP3A inhibitors
Patients taking moderate CYP3A inhibitors that cannot be avoided should have their dose of eplerenone reduced
Pregnancy & Lactation
Pregnancy Category: B
Lactation: unknown if excreted into breast milk, discontinue drug or nursing
Pregnancy Categories
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Pharmacology
Mechanism of Action
Selective aldosterone receptor antagonist; blocks aldosterone binding at the mineralocorticoid receptor
Pharmacokinetics
Half-Life: 3.5-6 hr
Peak Plasma Time: 1-2 hr
Bioavailability: 69%
Protein Bound: 50%
Vd: 43-90 L
Metabolism: primarily hepatic CYP3A4
Metabolite: no active mets identified
Total Body Clearance: 10 L/hr
Excretion: feces (32%) and urine (67%)
Images
Patient Handout
Formulary
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